Kornimate/medical-research-clean huggingface dataset:
pipac with nab-paclitaxel and cisplatin in peritoneal carcinomatosis

Conditions: Peritoneal Carcinomatosis

Summary: phase ib trial including investigating the combination of nab-paclitaxel and cisplatin in patients diagnosed with peritoneal carcinomatosis related to pancreatic, oeso-gastric, ovarian cancer or primitive peritoneal mesothelioma.

phase ib trial investigating the combination of intraperitoneal cisplatin (10.5 mg/m2) and nab-paclitaxel (escalated dose from 7.5 mg/m2 to 70 mg/m2) administered by pressurized intraperitoneal aerosol chemotherapy (pipac) every 4-6 weeks for 3 cycles.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * ≥18 years, * psychologically able to follow the trial procedures * with peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma, * ecog 0, 1 or 2, * life expectancy \> 3 months, * not candidate for surgical cytoreduction and ip/hipec based on expert multidisciplinary board * who received at least one line of chemotherapy and for whom standard therapies have been exhausted or not feasible. patients with residual disease following the first line of therapy or following secondary debulking are eligible. exclusion criteria: * predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary board, * bowel obstruction, active gastro-duodenal ulcer or ongoing abdominal infection (bacterial, viral or fungal), * chemotherapy or surgery within the last two weeks prior to enrollment, * previous intra-abdominal chemotherapy, * general or local (abdominal) contra-indications for laparoscopic surgery * known allergy to cisplatin or other platinum-containing compounds or to nab-paclitaxel, * severe renal impairment (calculated gfr (ckd-epi) \ 2, severe hepatic (serum total bilirubin \> 1.5 mg/dl), respiratory or neurologic impairment (grade 3), severe myocardial insufficiency (nyha class \> 2), recent myocardial infarction, severe arrhythmias, * pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception. * known or suspected non-compliance, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Keywords: pancreatic cancer oeso-gastric cancer epithelial ovarian cancer primitive peritoneal mesothelioma
evaluation of risk factors predictive of hypothermia in preterm neonates in incubators during the first week of life

Conditions: Hypothermia

Summary: preterm neonates less than 32 weeks of gestational age admitted at birth to the neonatal medicine unit will be included after informing the parents. abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. a case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. data will be recorded for the first 7 days of life of the preterm neonate.


Eligibility criteria:
inclusion criteria: * preterm infants of 25-32 weeks of gestation * birth in one of the two maternity hospitals of amiens agglomeration (cgo or clinic of europe ) * arrived in the neonatal medicine unit \< 2 hours of life * necessitated a care in an incubator exclusion criteria: * preterm infants \> 32 weeks of gestation * birth outside the amiens metropolitan area * arrived in the neonatal medicine unit after 2 hours of life * present a malformation syndrome or severe heart disease * pathology requiring support within the first 7 days of life * apgar score \< 5 to 10 minutes of life * need for initial management in open incubator * unavailability of a type of incubator " caleo® "

Keywords: hypothermia routine care preterm neonates
calcium intake, metabolism, and gestational blood pressure

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine if low dietary calcium intake and disturbances in maternal calcium metabolism were associated with increases in blood pressure in late pregnancy.

background: the importance of maintaining dietary calcium intake and normal calcium metabolism for optimal regulation of arterial blood pressure has been demonstrated in humans and animals. recent reports have suggested that low dietary calcium intake and disturbances in maternal calcium metabolism are associated with increases in blood pressure in late gestation. these factors may be associated with an increased risk of developing pregnancy-induced hypertension. this study was conducted in response to a request for applications on research on hypertension in pregnancy jointly released in 1986 by the national heart, lung, and blood institute and the national institute of child health and human development. design narrative: blood pressure, nutrient intake, and markers of calcium metabolism were prospectively assessed in normal, pregnant women. nutrient intakes, including dietary calcium, were assessed during gestation weeks 24, 28, 32, 36, and the postpartum period using 3-day food records and 24-hour dietary recalls. concomitantly, serum measures of calcium metabolism were assessed including serum total and ionized calcium, parathyroid hormone, calcitonin, vitamin d concentration, serum magnesium, phosphorus, sodium, and potassium concentrations. during weeks 24 and 32, urinary excretion of sodium, calcium, magnesium, potassium, phosphorus, camp, and creatinine were measured. blood pressures were measured at every prenatal visit and postpartum. measures of infant growth and blood pressure were assessed at 1, 6, and 12 months of age to determine if maternal dietary calcium intake exerted long-term influences on infant development and blood pressure. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
artificial intelligence-based disease management in the vulnerable period of heart failure

Conditions: Heart Failure

Summary: the study aims to evaluate the effect of ai-based discharge training after acute decompensation of heart failure on the patient's quality of life and to examine the relationship between changes in voice and speech characteristics of patients and changes in hospitalization, discharge, and early post-discharge clinical status.

heart failure (hf) is a progressive disease with a fluctuating course. from time to time, patients' symptoms and signs worsen enough to require hospitalization, and hospitalization occurs with acute decompensated hf. acute hf decompensations are periods that worsen the prognosis of the patient. on the other hand, patients discharged after an acute decompensation have the highest risk during the first months after discharge. patients get trained about lifestyle changes and medication management during the discharge period. recent guidelines suggest that patients in the early post-discharge period be called for virtual/telephone or face-to-face control visits at short intervals(3rd, 7th, 14th, and 28th days ), then at 3-6 monthly intervals according to nyha class. in traditional cardiovascular practice, patients are called for outpatient control visit in the first month after discharge. however, the processes after the pandemic kept patients away from visiting the hospital at the frequency recommended in the american and european guidelines and caused them to stay at home not even following their routine visit schedules. moreover, the risks and benefits of virtual visits in terms of patient prognosis are not well established. this study aims to investigate relationships between routinely recorded findings, symptoms, and vocal biomarkers of heart failure patients in the hospitalization and in the post-discharge period and to investigate the effect of post-discharge education on patient-reported outcomes and re-hospitalization.

Eligibility criteria:
inclusion criteria: * hospitalisation due to heart failure decompensation * having a smartphone with internet access * willingness to participate in the study * nyha 2-4 symptoms exclusion criteria: * diagnosis of active malignancy * pregnancy * vision and hearing problems * moderate to severe cognitive impairment * dementia

Keywords: heart failure vocal biomarker
tec4home blood pressure randomized controlled trial

Conditions: Hypertension

Summary: the goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (hbpt) and case management (cm), relative to usual care, for improving blood pressure (bp) control among patients with high blood pressure discharged from the emergency department (ed). the main question it aims to answer is: does telemonitoring with case management improve bp control, relative to usual care, for people with high blood pressure discharged from the ed? secondary research questions will address: 1. how do these interventions (telemonitoring and case management) improve medication adherence? 2. do these interventions reduce physician and ed visits? 3. are these interventions safe? 4. how do these interventions influence patient experience? participants in the intervention group will receive training and use of a home bp telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored bp data, and adjust medications. the control group will receive usual care from their primary care physician and will receive the same home bp monitor and hypertension education.


Eligibility criteria:
inclusion criteria: * adult patients aged ≥ 18 years of age * elevated triage bp and increased average bp in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic bp ≥ 160 mm hg or diastolic bp ≥ 100 mm hg) * own a smart phone * willing to measure and tele-transmit home bp readings exclusion criteria: * hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome * pregnant women * acute intoxication * acute surgical or trauma patients * psychiatrically unstable patients * advanced cognitive impairment * patient requiring admission to hospital * inability to use or care for home bp monitor correctly * from nursing home * unstable housing * non-english speaking or no family members who can help translate
metabolic response to the acute consumption of fiber-enriched pasta

Conditions: Healthy Volunteers

Summary: cardio-metabolic diseases are a leading cause of mortality worldwide. over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. the diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. in this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. however, worldwide the average fiber consumption is still less than the recommended daily dose. for this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.


Eligibility criteria:
inclusion criteria: * bmi 18-29 kg / m2 * good health status exclusion criteria: * diabetes * cardiovascular events (ima or stroke) severe heart disease * kidney or liver failure * anemia and any other chronic disease
effects of distraction on pain and distress during venepuncture in children

Conditions: Hospitalism in Children; Pain

Summary: the main purpose of this study is investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.


Eligibility criteria:
inclusion criteria: * 5-7 years old * understanding numeral exclusion criteria: * mental retard and can not nuderstand numeral

Keywords: venepuncture distraction distress
long term safety and efficacy of solesta® injectable bulking agent for the treatment of fecal incontinence (sofi)

Conditions: Fecal Incontinence

Summary: the purpose of this observational study is to evaluate the safety and effectiveness of the solesta injectable bulking agent in the treatment of fecal incontinence through 3 years in a real world setting.

this observational study is to evaluate the safety and effectiveness of the solesta injectable bulking agent in the treatment of fecal incontinence through 3 years in a real world setting.

Eligibility criteria:
inclusion criteria: a patient will be eligible for study participation if he/she meets the following criteria: * able to fluently speak and understand the language in which the study is being conducted and able to provide meaningful written informed consent for the study. * have fi, have failed conservative therapy (e.g., diet, fiber therapy, medications that treat diarrhea), and are scheduled to receive solesta treatment. * females must be of non-childbearing potential; or females of childbearing (reproductive) potential must agree to use an acceptable method of contraception for at least the first 6 months of study participation and have a negative urine pregnancy test at visit 1 (screening/baseline) and immediately prior to receiving initial solesta treatment. women who are surgically sterile or those who are post menopausal for at least 2 years prior to entering the study are not considered to be of childbearing potential. * willing to return to the study facility for the post treatment evaluation. exclusion criteria: a patient will be excluded from the study if he/she meets any of the following criteria: * is currently pregnant, breastfeeding, or is planning to become pregnant over the course of the study. * has an active inflammatory bowel disease. * has an immunodeficiency disorder or ongoing immunosuppressive therapy. * has received previous radiation treatment to the pelvic area. * has significant mucosal or full thickness rectal prolapse. * has active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections. * has anorectal atresia, tumors, stenosis or malformation. * has a rectocele. * has rectal varices. * has presence of existing implant including solesta, artificial bowel sphincter, or sacral nerve stimulator (activated or inactivated). * has an allergy to hyaluronic acid (ha) based products. * has an anastomosis to the rectum or anus within 10 cm of the dentate line. * has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the requirements of the post-approval study protocol. * has any disorder that, in the opinion of the investigator, might interfere with the conduct of the study. * has undergone sphincteroplasty, graciloplasty, or other surgical interventions (without the use of an implanted device) for treatment of fecal incontinence within 12 months of enrollment. * has any bleeding disorder.
a study to obtain normal values of inflammatory variables from healthy subjects

Conditions: Asthma; Copd

Summary: smoking induces an inflammatory reaction in the airways which can ultimately result in persistent damage and the development of a chronic obstructive pulmonary disease (copd). however, not all subjects who smoke end up with copd. after long-term smoking, approximately 20% of subjects develop copd. at this time, it is unclear why some subjects develop copd, whereas others maintain a normal lung function. in addition, smoking has important consequences in asthma. patients with asthma who smoke have a more severe asthma and more often experience an asthma exacerbation. in addition, it has been shown that inhaled corticosteroids are less effective in smoking asthmatics. with this research project, the researchers will investigate the effects of smoking on the airways. to this end, the researchers will compare markers of airway inflammation, lung function and symptoms between healthy smokers and non-smokers of varying age. in addition, the researchers will compare those healthy subjects with patients with asthma and copd which are characterized in earlier studies.


Eligibility criteria:
inclusion criteria: * have not smoked during the last year. * have never smoked for as long as a year. * have \< 0.5 packyear. exclusion criteria: * persons who used inhaled or oral corticosteroids during \>5 years, or within the last 5 years. * fev1 \<1.2 l * a subject is not eligible to enter and participate if he does not agree that we inform his general practicioner about participation in the study and also about any unexpected finding during the study. * upper respiratory tract infection (e.g. colds), within 2 months. * pregnancy, or the possibility of being pregnant (i.e. women who do not use adequate anticonception as judged by the investigator). * malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). * signs or symptoms of any other concomitant disease that, in the eyes of the investigator, can interfere with the study results. * known recent substance abuse (drug or alcohol). * claustrophobia.

Keywords: bronchial copd asthma sputum biopsies
study of b/f/taf in participants switching from cab + rpv to b/f/taf for hiv-1 infection (empower)

Conditions: HIV-1-infection

Summary: the goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of bictegravir/emtricitabine/tenofovir (b/f/taf) from cabotegravir + rilpivirine (cab+rpv) in participants living with virologically suppressed human immunodeficiency virus type 1 (hiv-1), meaning participants with hiv rna levels below detectable levels. the primary objective of this study is to assess the safety of switching to b/f/taf in virologically suppressed participants unable/unwilling to continue on cab+rpv intramuscular (im) injections or wishing to switch to oral therapy through week 12.


Eligibility criteria:
key inclusion criteria: * people with hiv-1 (pwh) or provider decision to switch off cab+rpv im injections due to intolerance, inconvenience, adverse events (aes), or willing to switch to (and intention to remain on) daily b/f/taf * currently virologically suppressed (hiv-1 rna \< 50 copies/ml) on cab+rpv im injections every 2 months * currently on cab+rpv im injections every 2 months and received at least one dose of cab+rpv im injection; no missed cab+rpv injections * ability to receive b/f/taf up to 7 days prior to the next scheduled dose of cab+rpv * documented plasma hiv-1 rna \< 50 copies/ml during treatment for ≥ 6 months preceding the screening visit * no documented or suspected resistance to bic, emtricitabine (ftc), or tenofovir (tfv). key exclusion criteria: * history of b/f/taf intolerance * history of previous insti virologic failure including cab+rpv * requirement for ongoing therapy with any prohibited medications listed in local prescribing information for b/f/taf starting within 30 days prior to screening until 30 days following the last dose of study drug * have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies) * need for oral antiretroviral therapy (art) bridge or use of other antiretroviral (arv) agents prior to starting b/f/taf on day 1 note: other protocol defined inclusion/exclusion criteria may apply.
motor learning and tdcs in parkinson's disease

Conditions: Parkinson Disease

Summary: the present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with parkinson's disease on sequential motor learning performance.

parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. beyond the visibly recognisable motor symptoms of parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. in healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. the present study sought to examine the effect of a single session of transcranial direct current stimulation applied over the primary motor cortex in people with parkinson's disease on sequential motor learning performance. participants learnt two finger tapping sequences, with task difficulty indexed by sequence length, and task consolidation further examined using a dual-task paradigm. task related cortical haemodynamic activity was recorded using functional near-infrared spectroscopy.

Eligibility criteria:
inclusion criteria: * right-handed (edinburgh handedness inventory; ≥50) * cognitively capable (montreal cognitive assessment (moca); ≥23) * mild to moderate parkinson's disease severity (hoehn and yar disease stage 2-3) exclusion criteria: * history of stroke * comorbidity * cephalic implants

Keywords: parkinson's disease transcranial direct current stimulation motor sequence learning
natural course and therapeutic effect of recurrent acute pancreatitis

Conditions: Cohort Study; Recurrent Acute Pancreatitis

Summary: the goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. the main question it aims to answer is: does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? what are the risk factors affecting the recurrence of acute pancreatitis? patients will be closely followed and clinical information will be recorded.

acute pancreatitis is one of the most common causes of acute hospital admission, which is unpredictable and contributes to high health-care costs even death. recurrent acute pancreatitis is defined as two or more discrete episodes of acute pancreatitis, and has an estimated annual incidence of 8-10 per 100 000. cholelithiasis, alcohol and hyperglyceremia are the most commonly recognized causes of acute pancreatitis. about 80% of rap patients can be identified through routine investigations identify (include proper history, physical examination, ct, mri, endoscopic ultrasound); however, in up to 20% of cases whose cause remains unclear are known as idiopathic rap. for rap patients with clear cause, removal of the cause can effectively reduce or prevent recurrence. for patients with idiopathic rap, the treatment options are not clear and have been subject to debate. at present, the natural course, outcome and therapeutic effect of rap is still not clear. therefore, the prospective cohort can clarify the clinical characteristics of rap more comprehensively and deeply and to accumulate evidence for treatment.

Eligibility criteria:
inclusion criteria: * patients with recurrent acute pancreatitis. exclusion criteria: * unwilling or unable to provide consent.

Keywords: recurrent acute pancreatitis natural course therapeutic effect